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Published on: September 17, 2014
[Development of L-OHP (trade name; Elplat)]
1Yakult Honsha Co., Ltd.
Abstract:
L-OHP (INN: oxaliplatin) was created in 1976 by Dr. Kidani. The experimental tumor models showed its antitumor activities, however, clinical investigations were not conducted in Japan. It was licensed to Debiopharm in Switzerland, and obtained the marketing authorization with the indication of colorectal cancer in France in 1996, and in the USA in 2002. The marketing authorization was given with the same indication in Japan in March, 2005. L-OHP is now widely used in the world as one of the key agents for treatments of colorectal cancers like 5-FU and CPT-11.
Insights
Oxaliplatin (L-OHP), developed in 1976, demonstrates significant antitumor activity. It is now a key treatment for colorectal cancer globally, approved in major markets including Japan, France, and the USA.
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- Oxaliplatin (L-OHP) was synthesized in 1976.
- Early studies indicated antitumor properties in experimental models.
- Clinical development and regulatory approvals occurred significantly later.
Purpose of the Study:
- To provide a historical overview of Oxaliplatin (L-OHP) development.
- To document its regulatory journey and market authorization.
- To establish its current role in colorectal cancer treatment.
Main Methods:
- Literature review of Oxaliplatin (L-OHP) development and approvals.
- Analysis of clinical and regulatory milestones.
- Comparison with existing colorectal cancer therapies.
Main Results:
- Oxaliplatin (L-OHP) received marketing authorization in France (1996), USA (2002), and Japan (2005).
- It is recognized for its efficacy in treating colorectal cancer.
- It is now a widely used agent alongside 5-FU and CPT-11.
Conclusions:
- Oxaliplatin (L-OHP) has evolved from experimental compound to a globally significant colorectal cancer therapeutic.
- Its strategic licensing and phased regulatory approvals facilitated widespread clinical adoption.
- Oxaliplatin (L-OHP) is a cornerstone in modern combination chemotherapy for colorectal malignancies.
